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EFFICACY OF INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING RARP FOR THE TREATMENT OF PROSTATE CANCER

NCT06822036 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2026-05-29

No results posted yet for this study

Summary

We perform a multicenter randomized controlled prospective study with superiority trial design, in which the polysaccharide ARISTA™ AH hemostat agent is applied to the neurovascular bundle areas after prostate removal, during Robot-assisted radical prostatectomy.

We examine if such agent leads to a relevant clinical improvement indicated by higher postoperative hemoglobin levels compared to the control group. As an exploratory co-primary endpoint of interest, we examine erectile function after Robot-assisted radical prostatectomy based on IIEF-5 score between groups 3, 6 and 12 months after Robot-assisted radical prostatectomy

Conditions

  • Prostate Cancer (Adenocarcinoma)
  • Blood Loss, Postoperative
  • Erectile Function

Interventions

PROCEDURE

Arm A - Application of 5g of ARISTA™ AH

Perioperative application of 5g of ARISTA™ AH to the prostate bed and neurovascular bundles during and at the end of the surgery to control bleeding and oozing in accordance with labelled directions; no other hemostyptic agent in aforementioned area

Sponsors & Collaborators

  • Becton, Dickinson and Company

    collaborator INDUSTRY

  • University of Leipzig

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    collaborator OTHER

  • St. Antonius Hospital Gronau

    lead OTHER

Principal Investigators

  • Sami-Ramzi Leyh-Bannurah, PD · Klinik für Urologie, Urologische Onkologie und Roboter-assistierte Chirurgie

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
68 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-16
Primary Completion
2027-01-30
Completion
2027-01-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06822036 on ClinicalTrials.gov